CN116490143A

CN116490143A - Interspinous implant

Info

Publication number: CN116490143A
Application number: CN202180071441.9A
Authority: CN
Inventors: M·福罗克; A·福罗克; T·莫斯利; A·罗杰斯
Original assignee: Spinal Simplicity LLC
Current assignee: Spinal Simplicity LLC
Priority date: 2020-08-20
Filing date: 2021-08-05
Publication date: 2023-07-25
Also published as: US11311389B2; EP4199847A1; US20220054280A1; US11311388B2; CA3189701A1; US20220054279A1; JP2023543118A; AU2021328118A1; WO2022039935A1

Abstract

The present invention relates to a system and method for providing a spinal implant having a body, a proximal anchor, a distal anchor, and an inner plunger. The proximal anchor includes a nut having an internal bore. The distal anchor includes a plurality of wings having a first closed configuration and a second open configuration. The inner plunger is received within the central bore of the body. The distal end of the inner plunger is operatively connected to first and second wings to selectively move the wings between the first closed configuration and the second open configuration, and vice versa.

Description

Interspinous implant

Technical Field

Embodiments of the present invention relate to spinal implants. More particularly, embodiments of the present invention relate to percutaneous or posteriorly introduced spinous process implants and fusion devices.

Background

The spine consists of a series of twenty-four vertebrae extending from the skull to the buttocks. The soft tissue disc is positioned between adjacent vertebrae. In addition, the spine encloses and protects the spinal cord, defining a bone channel, called a spinal canal, around the spinal cord. There is typically a space between the boundaries of the spinal cord and the spinal canal so that the spinal cord and nerves associated therewith are not compressed.

Over time, the ligaments and bone surrounding the spinal canal become thicker and harden, resulting in a narrowing of the spinal canal and compression of the spinal cord or nerve root. This condition is known as spinal stenosis, resulting in back and leg pain and numbness, weakness, and/or loss of balance. These symptoms often worsen after walking or standing for a period of time.

There are many non-surgical treatments for spinal stenosis. These include non-steroidal anti-inflammatory drugs that reduce swelling and pain, and corticosteroid injections that reduce swelling and treat acute pain. While some patients may alleviate symptoms of spinal stenosis by such treatment, many patients are unable and therefore turn to surgical treatment. The most common surgical procedure for treating spinal stenosis is laminectomy, which involves removal of a portion of the vertebrae. The purpose of the procedure is to relieve spinal cord and nerve stress by increasing the area of the spinal canal.

Interspinous reduced pressure (IPD) is a minimally invasive surgical procedure for treating spinal stenosis. For IPD surgery, no bone or soft tissue removal is required. Instead, an implant or spacer is placed between the posterior aspect of the spinal cord or nerve and between the spinous processes protruding from the vertebrae of the lower back.

Examples of particularly useful interspinous implants and fusion devices are disclosed in commonly assigned U.S. patent No. 9,861,399; U.S. patent No. 8,945,184; U.S. patent No. 9,314,276; U.S. patent No. 9,907,581 and U.S. patent No. 9,757,164, the disclosures of which are incorporated herein by reference in their entirety.

The present invention provides improvements over prior interspinous implant devices by constructing implants that are much shorter in length than prior devices. This will advantageously reduce the overall size and profile of the device, thereby making implantation safer and easier.

The configuration of the implant according to embodiments of the present invention also allows for easier removal of the device after implantation, if desired. The ability of the surgeon to selectively open and close the wings of the device is another advantage over previous devices. Because the wings can be closed after implantation, the implant of the present invention can be removed through the same small lateral incision through which it was initially inserted. Removal of the prior devices typically required an additional posterior incision to manually close the wings prior to removal of the device.

Additionally, the device of the present invention does not require a removable end piece. This improves the safety and ease of the procedure by reducing the number of steps in the implantation process. Fewer detachable portions of the implant also reduce cost and simplify manufacture.

Disclosure of Invention

Embodiments of the present invention address the above stated problems by providing a system and method for minimally invasive spinal fusion.

A first embodiment of the invention is directed to a spinal implant comprising: a body, a proximal anchor, a distal anchor, and an inner plunger. The body has an outer surface, a central bore therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The proximal anchor includes a nut having a proximal side, a distal side, and an interior bore. The distal anchor includes a plurality of wings having a first closed configuration and a second open configuration, wherein the plurality of wings includes a first wing and a second wing. The inner plunger has a proximal end, a distal end, and is received within the central bore of the body. The distal end of the inner plunger is operatively connected to the first wing and the second wing to selectively move the plurality of wings between the first closed configuration and the second open configuration.

Further embodiments of the present invention relate to a spinal implant comprising a body, a proximal anchor, a distal anchor, and a linkage assembly. The body has an outer surface, a central bore therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The body includes external threads on at least a portion of the outer surface. The proximal anchor includes a nut having proximal, distal and internal bores with internal threads. The distal anchor includes a first wing and a second wing configured to selectively open and close. The linkage assembly connects the first wing and the second wing to the body.

Another embodiment of the invention is directed to a method of placing a spinal implant at a treatment site, the method comprising: providing a spinal implant in a first closed configuration; placing the spinal implant at a desired treatment site within a patient; and sliding the inner plunger distally along the longitudinal axis to move the plurality of wings to the second open configuration. The method may further include sliding the inner plunger proximally along the longitudinal axis to move the plurality of wings to the first closed configuration to remove the spinal implant from the patient.

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Other aspects and advantages of the present invention will become apparent from the following detailed description of the embodiments and the accompanying drawings.

Drawings

Embodiments of the invention are described in detail below with reference to the attached drawing figures, wherein:

FIG. 1 is a perspective view of a first embodiment of the implant of the present invention in an open configuration;

FIG. 2 is a cross-sectional view of a first embodiment of the implant of the present invention in an open configuration;

FIG. 3 is a perspective view of an embodiment of the body of the present invention;

FIG. 4 is a perspective view of a first embodiment of the implant of the present invention in a closed configuration;

FIG. 5 is a perspective view of an embodiment of a plunger of the present invention;

FIG. 6A is a perspective view of an embodiment of a first link of the present invention;

FIG. 6B is a perspective view of an embodiment of a second link of the present invention;

FIG. 7 is another perspective view of the first embodiment of the implant of the present invention in an open configuration;

FIG. 8 is a cross-sectional view of a first embodiment of the implant of the present invention in an open configuration;

FIG. 9A is a side perspective view of a first embodiment of a first wing of the present invention;

FIG. 9B is a bottom perspective view of a first embodiment of the first wing of the present invention;

FIG. 9C is a top view of a first embodiment of a first airfoil of the invention;

FIG. 10A is a side perspective view of a first embodiment of a second wing of the present invention;

FIG. 10B is a bottom perspective view of the first embodiment of the second wing of the present invention;

FIG. 10C is a top view of the first embodiment of the second wing of the present invention;

FIG. 11 is a perspective view of a bolt of the present invention;

FIG. 12 is a perspective view of a removable top cover of the bolt of the present invention;

FIG. 13 is a perspective view of an embodiment of the nut of the present invention;

FIG. 14 is a cross-sectional view of a first embodiment of the implant of the present invention in a closed configuration;

FIG. 15 is another cross-sectional view of the first embodiment of the implant of the present invention in a closed configuration; and is also provided with

Fig. 16 is a view of a first embodiment of the implant of the present invention implanted in a patient's spine.

The drawings are not intended to limit the invention to the specific embodiments disclosed and described herein. The drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present invention.

Detailed Description

The following detailed description refers to the accompanying drawings that illustrate specific embodiments in which the invention may be practiced. These embodiments are intended to describe aspects of the invention in sufficient detail to enable those skilled in the art to practice the invention. Other embodiments may be utilized and changes may be made without departing from the scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense. The scope of the invention is defined only by the appended claims, along with the full scope of equivalents to which such claims are entitled.

Reference in the specification to "one embodiment," "an embodiment," or "an embodiment" means that one or more of the features mentioned are included in at least one embodiment of the technology. Separate references in the specification to "one embodiment," "an embodiment," or "an embodiment" do not necessarily refer to the same embodiment and are not mutually exclusive unless so stated and/or unless one of ordinary skill in the art will readily appreciate from the specification. For example, features, structures, acts, etc. described in one embodiment may be included in other embodiments as well, but are not necessarily included therein. Thus, the techniques may include various combinations and/or integration of the embodiments described herein.

Embodiments of the present invention relate to a minimally invasive interspinous-interlaminar fusion device for temporarily securing the thoracic, lumbar and sacral vertebrae while waiting for bone fusion to occur. The implant may be attached to the posterior non-cervical spine at the spinous processes to provide fixation and stabilization of the spinal column segment. The threaded body of the implant provides controlled separation.

Fig. 1 illustrates one embodiment of the present invention showing an interspinous implant 100 in an open configuration. Implant 100 may include a body 112 having a distal end 114 and a proximal end 116. The implant 100 further includes a nut 200 on the proximal end 116 of the body 112 and extendable first and second wings 300a, 300b on the distal end 114 of the body 112. As can be seen in the cross-sectional view of fig. 2, the implant 100 further includes a plunger 400 and first and second links 500a, 500b for operatively connecting the first and second wings 300a, 300b to the body 112, as will be described herein.

Fig. 3 illustrates an embodiment of the body 112. Distal end 114 includes a conical distal tip 118 having a rounded distal-most end. In some embodiments, the conical distal tip has a sharp pointed distal-most end. In some embodiments, the body 112 includes a helical thread 120 on an outer surface thereof. In some embodiments, the body 112 may alternatively or additionally include cut threads or female threads. The helical thread 120 may be disposed along the entire outer surface of the body 112, or along only a portion of the outer surface of the body 112. In some embodiments, the threads may have a depth of about 0.5 to about 3.0mm, an angle of about 45 ° to about 100 °, and a pitch of about 1.0mm to about 4.0mm. In some embodiments, the threads may have a depth of about 1.0mm, an angle of about 60 ° and a pitch of about 1.75mm. In some embodiments, distal tip 118 has a smooth outer surface without any threads thereon. In some embodiments, distal tip 118 is a solid tip for providing strength during insertion of implant 100.

The body 112 further includes a proximal portion 122 extending from the proximal end 116 having a hollow bore 124. A majority of the hollow bore 124 may be substantially cylindrical. The proximal end of the hollow bore 124 may have a particular shape, such as a hexagonal perimeter, configured to receive an insertion tool (not shown) therein. The proximal end of the hollow bore 124 may also contain a pawl 125 adapted to receive and lock the distal end of an insertion tool (not shown) therein.

The body 112 also includes a distal portion 126 extending from the distal end 114 having a substantially rectangular window 128. Window 128 extends from first side 130 to second side 132, top planar inner wall 134, and bottom planar inner wall 136. At the distal end of window 128, top wall 134 includes an opening 138a therethrough and bottom wall 136 includes an opening 138b therethrough. The openings 138a, 138b are configured to receive bolts 700 for mounting the wings 300a, 300b, as shown in fig. 4.

Fig. 4 and 15 illustrate the implant 100 with wings 300a, 300b in a closed configuration. The window 128 of the body 112 is configured to receive the distal portion of the plunger 400, the first and second links 500a, 500b, and the first and second wings 300a, 300b when in the closed configuration.

Fig. 5 illustrates an embodiment of a plunger 400. Plunger 400 has a distal end 402 and a proximal end 404. As shown in fig. 2, the proximal end 404 is configured to be positioned within the bore 124 of the body 112 and the distal end 402 is configured to be positioned within the window 128 of the body 112. The plunger 400 may be longitudinally movable within the bore 124 and window 128 to open and close the wings 300a, 300b, as will be described further below.

With respect to fig. 5, the proximal end of the plunger 400 has a central bore 406 for receiving an inserter device (not shown) therein. In some embodiments, the central bore 406 of the plunger 400 may be threaded to cooperate with threads on an inserter device. The plunger 400 has a substantially Y-shaped configuration with a first arm 408a and a second arm 408b extending from a solid central portion 410. There is a space 409 between the first arm 408a and the second arm 408b. The central portion 410 has two opposing curved recesses 412a, 412b on the outside, as can be seen in fig. 5. The first arm 408a and the second arm 408b each have a hole 414a, 414b extending therethrough for receiving the mounting pin 600 therein. To connect wings 300a, 300b to plunger 400, links 500a, 500b are installed in space 409 between arms 408a, 408b.

In an alternative embodiment, the plunger may have two caps with a T-shaped or dovetail feature that straddles in mating grooves on the underside of the wings 300a, 300b. In a further alternative embodiment, the plungers may be connected by umbrella-like features having links that straddle in grooves on the underside of the wings 300a, 300b.

Fig. 6A and 6B illustrate an embodiment of a first link 500a and a second link 500B, respectively. The first link 500a has a first end 502a and a second end 504a. In some embodiments, the first link 500a is substantially elliptical, the first end 502a has a rounded edge 506a, and the second end 504a has a rounded edge 508a. The first link 500a further includes a straight top edge 510a and a serrated curved bottom edge 512a. The first end 502a includes an aperture 514a extending therethrough and the second end 504a includes an aperture 516a extending therethrough. The holes 514a and 516a are each configured to receive the mounting pin 600 therein. The first link 500a includes a substantially flat top surface 518a and a substantially flat bottom surface 520a.

As can be seen in fig. 6B, the second link 500B is substantially identical to the first link 500 a. The second link 500b has a first end 502b and a second end 504b. In some embodiments, the second link 500b is substantially elliptical, the first end 502b has a rounded edge 506b, and the second end 504b has a rounded edge 508b. The second link 500b further includes a straight top edge 510b and a serrated curved bottom edge 512b. The first end 502b includes an aperture 514b extending therethrough and the second end 504b includes an aperture 516b extending therethrough. The holes 514b and 516b are each configured to receive the mounting pin 600 therein. The second link 500b includes a substantially flat top surface 518b and a substantially flat bottom surface 520b.

Fig. 7 shows a perspective view of implant 100 in an open configuration with wings 300a shown in front. As can be seen in fig. 7, the first link 500a and the second link 500b are mounted in the space 409 between the arms 408a, 408b of the plunger 400.

Fig. 8 shows a cross-sectional view of implant 100 in an open configuration. As can be seen in fig. 8, the second end 504a of the first link 500a is connected to the first end 502b of the second link 500 b. The flat bottom surface 520a of the first link 500a is placed in contact with the flat top surface 518b of the second link 500 b. As can be seen in fig. 2 and 8, the mounting pin 600 is inserted through the hole 516a in the second end 504a of the first link 500a, the hole 514b in the first end 502b of the second link 500b, the hole 414a in the first arm 408a of the plunger 400, and the hole 414b in the second arm 408b of the plunger 400 to allow the links 500a, 500b to rotate thereabout. The opposite ends of the links 500a, 500b are connected with the wings 300a, 300b to allow rotation thereof, as will be described further below.

Fig. 9A, 9B and 9C show perspective views of an embodiment of the first wing 300 a. The wing 300a has a distal end 302a, a proximal end 304a, a first side 306a, and a second side 308a. In some embodiments, distal end 302a includes at least one tooth extending therefrom adapted to engage bone and/or tissue. In other embodiments, the bottom surface of wing 300a may include a flat roughened surface to enable gripping of bone and/or tissue.

In some embodiments, distal end 302a includes a first tooth 310a and a second tooth 311a with a gap 312a therebetween. In some embodiments, the gap 312a may be about 1.5mm to about 6mm in size. In some embodiments, gap 312a may be about 3mm. In some embodiments, the first tooth 310a has a sharp pointed tip 314a and the second tooth 311a has a sharp pointed tip 313a. The first tooth 310a is disposed on the first side 306a and is coupled to the first extension 316 a. The second tooth 311a is disposed on the second side 308a and is connected to the second extension 318 a. The first extension 316a has a width d1 and the second extension 318a has a width d2. In some embodiments, the width d2 is greater than the width d1. In some embodiments, the width d1 ranges from about 1.0mm to about 4.0mm. In some embodiments, the width d2 ranges from about 1.5mm to about 6.0mm. A substantially rectangular slot 320a is provided between the first extension 316a and the second extension 318a for receiving the first end 502a of the first link 500a therein, as can be seen in fig. 1, 2 and 7. The first extension 316a includes a hole 322a in an inner wall thereof for receiving the pin 600 therein. In some embodiments, the aperture 322a does not extend completely through the wall of the first extension 316 a. The second extension 318a includes a hole 324a extending therethrough that is located opposite the hole 322a of the first extension 316 a. The mounting pin 600 is inserted into the hole 322a of the first extension 316a, the hole 514a of the first link 500a, and the hole 324a of the second extension 318a to allow the wing 300a to rotate thereabout.

The wing 300a includes a substantially flat top surface 330a, as can be seen in fig. 9C. The wing 300a includes a substantially rectangular opening 332a adjacent the top surface 330 a. The rectangular opening 332a is adapted to receive the first end 502a of the first link 500a therein in the closed configuration of the wing 300 a. The proximal end 304a of the wing 300a further includes a proximal connector portion 326a having an additional aperture 328a for operatively connecting the wing 300a to the body 112. The hole 328a is configured to receive the bolt 700 therein.

Fig. 10A, 10B and 10C show perspective views of an embodiment of the second wing 300B. The second wing 300b is substantially identical to the first wing 300 a. Wing 300b has a distal end 302b, a proximal end 304b, a first side 306b, and a second side 308b. In some embodiments, distal end 302b comprises at least one tooth adapted to engage bone and/or tissue. In other embodiments, the bottom surface of the wings 300b may include a flat roughened surface to enable gripping of bone and/or tissue.

In some embodiments, distal end 302b includes a first tooth 310b and a second tooth 311b with a gap 312b therebetween. In some embodiments, the gap 312b may be about 1.5mm to about 6mm in size. In some embodiments, gap 312b may be about 3mm. In some embodiments, the first tooth 310b has a sharp pointed tip 314b and the second tooth 311b has a sharp pointed tip 313b. The first tooth 310b is disposed on the first side 306b and is coupled to the first extension 316 b. The second tooth 311b is disposed on the second side 308b and is connected to the second extension 318 b. The first extension 316b has a width d1 and the second extension 318b has a width d2. In some embodiments, the width d2 is greater than the width d1. A substantially rectangular slot 320b is provided between the first extension 316b and the second extension 318b for receiving the second end 504b of the second link 500b therein, as can be seen in fig. 2. The first extension 316b includes a hole 322b in an inner wall thereof for receiving the pin 600 therein. The second extension 318b includes a hole 324b extending therethrough that is located opposite the hole 322b of the first extension 316 b. The mounting pin 600 is inserted through the hole 322b of the first extension 316b, the hole 516b of the second link 500b, and the hole 324b of the second extension 318b to allow the wing 300b to rotate thereabout, as can be seen in fig. 2.

The wing 300b includes a substantially flat top surface 330b, as can be seen in fig. 10C. Wing 300b includes a substantially rectangular opening 332b adjacent top surface 330 b. The rectangular opening 332b is adapted to receive the second end 504b of the second link 500b therein in the closed configuration of the wing 300b. The proximal end 304b of the wing 300b further includes a proximal connector portion 326b having an additional aperture 328b for operatively connecting the wing 300b to the body 112. The hole 328b is configured to receive the bolt 700 therein.

In some embodiments, in the open position, the wings 300a, 300b extend circumferentially from the body 112 a distance of about 2mm to about 15mm, which may be referred to as the extension R of the wings 300a, 300b ₁ . In some embodiments, the spacing of the gap 312a between the teeth 310a, 311a may be the same as the spacing of the gap 312b between the teeth 310b, 311b. In other embodiments, the spacing of the gap 312a between the teeth 310a, 311a may be different than the spacing of the gap 312b between the teeth 310b, 311b. The teeth 310a, 311a, 310b, 311b are optimally placed to minimize stress on the spinous processes and prevent them from breaking. Any of the teeth 310a, 311a, 310b, 311b may have a length of about 0.5mm to about 5mm. In some embodiments, each tooth may have a different length as desired.

The design of the wings 300a, 300b is such that the outer surface acts as a stop against the body 112 to control minimum and maximum movement, thereby preventing self-closure inside the body 112 and also preventing over-deployment.

Fig. 11 illustrates an embodiment of a bolt 700 and fig. 12 illustrates an embodiment of a removable top cover 718 for connection with the bolt 700. Bolt 700 includes a shaft 702 having a proximal end 704 and a distal end 706. Proximal end 704 includes an integral cap 708 having a rounded distal end 710, a side circumferential edge 712, and a flat bottom surface 714. Distal end 706 includes a reduced diameter cylindrical portion 716. The shaft 702 may be inserted through the aperture 328a of the wing 300a, the aperture 328b of the wing 300b, and through the openings 138a, 138b of the body 112. Thus, proximal connector portion 326a of wing 300a is adjacent to and connected with proximal connector portion 326b of wing 300b by bolt 700. The diameter of the shaft 702 is configured to fit through the holes 328a, 328b and allow the wings 300a, 300b to freely rotate thereabout. Once the bolt 700 is inserted through the body 112 and wings 300a, 300b, a removable top cover 718 may be coupled with the cylindrical portion 716 to securely hold the bolt 700 in place. The top cover 718 may be attached by any mechanical fastening means. As shown in fig. 12, the shape of the embodiment of the removable top cover 718 is similar to the shape of the integral top cover 708 having a rounded distal end 720, a side circumferential edge 722, and a planar bottom surface 724. The top cover 718 and the top cover 708 are disposed within the openings 138a, 138b such that the distal ends 710, 720 are recessed and do not extend circumferentially beyond the helical thread 120, as shown in fig. 4.

Fig. 13 illustrates an embodiment of a nut 200. The nut 200 may be disposed on the proximal end 116 of the body 112. Nut 200 has a proximal side 202, a distal side 204, and an inner bore 206 therethrough. In some embodiments, the internal bore 206 has internal helical threads 208 for cooperating with the helical threads 120 on the outer surface of the body 112. In operation, nut 200 may be rotated to move the nut longitudinally along the axis of body 112 such that distal side 204 engages tissue and/or bone. In some embodiments, the proximal side 202 has a hexagonal extension 210 with flat sides 212. In some embodiments, the distal side 204 forms a grip plate with a plurality of flex arms 214. In one embodiment, the grip plate includes four flexing arms 214. In other embodiments, the grip plate may include two flex arms, three flex arms, or five or more flex arms.

In some embodiments, each flexure arm 214 may have a fixed portion 216 with a smooth top surface 218 and a movable portion 220 with a textured top surface 222. The movable portion 220 may have a space 226 thereunder. The textured top surface 222 is configured to engage bone or tissue when the implant is placed in the body to help anchor the implant 100 in place. The movable portion 220 is configured to flex into the open space 226 when the implant 100 is engaged with tissue and/or bone. In some embodiments, the movable portion 220 may be bent proximally an amount of about 1 degree to about 50 degrees. In some embodiments, the movable portion 220 may be bent proximally an amount of about 1 degree to about 10 degrees. In some embodiments, the textured top surface 222 may include teeth, spikes, or any other type of mechanical gripping surface. In one embodiment, the textured top surface 222 may comprise three substantially triangular teeth 224. In other embodiments, the distal side 204 has an overall circumferentially roughened or textured surface without any flexing arms. The nut 200 extends circumferentially from the body 112 a distance of about 2mm to about 15 mm. In some embodiments, the nut 200 extends circumferentially a distance of about 2mm to about 8 mm. This extension allows for adequate bone fixation while ensuring that implant 100 can be easily inserted through standard tissue dilating cannulas/tubes.

Implant 100 may be provided in different selected sizes to appropriately fit the desired space of a particular patient. The implant body diameter may provide a spinous process spatial separation in the range of about 6-20 mm. In some embodiments, the diameter of the body 112 may be about 8mm, about 10mm, about 12mm, about 14mm, or about 16mm. The size of the implant may be color coded to allow the surgeon to easily size the implant and match the implant with an appropriately sized insertion tool (not shown), which may have a similar size color coding.

In some embodiments, all or part of the implant may be composed of titanium or titanium alloy. In other embodiments, all or part of the implant may be constructed of stainless steel. In some embodiments, all or part of the implant may be composed of a polymer or bioabsorbable material. In some embodiments, the implant may be manufactured by an additive manufacturing process. In some embodiments, the implant may be manufactured by machining or molding. In some embodiments, all or part of the implant may comprise a coating on at least one surface thereof. In some embodiments, at least one outer surface of the implant may be coated with Hydroxyapatite (HA).

In some embodiments, the total length of the implant may be about 30mm to 45mm. In some embodiments, the total length of the implant may be about 32mm to about 34mm. In some embodiments, the total length of the implant may be about 33mm.

In some embodiments, the body 112 may be adapted to contain bone graft material therein. Bone graft material may be added to implant 100 by holding wings 300a open and holding wings 300b closed and injecting bone graft material into body 112 (and vice versa). Bone graft material may also be applied around the external helical thread 120 prior to insertion of the implant 100 into the body. In some embodiments, the bone graft material may be adhesive to avoid any interference with the normal function of the wings 300a, 300b. Depending on the size of the implant 100, the volume of bone graft material may range from about 0.5cc to about 3.0cc or from about 1.2cc to about 2.5cc.

The implant 100 may be inserted into the body of a patient in a closed configuration using an inserter device (not shown), as shown in fig. 4, 14 and 15. With respect to fig. 14 and 15, the plunger 400 is in the proximal position such that the first and second links 500a, 500b form a first angle a therebetween, and the wings 300a, 300b are in the closed configuration. Once the implant 100 is inserted into the desired location within the patient, the wings 300a, 300b may be moved to the open configuration, as shown in fig. 1, 2, 7, and 8. The plunger 400 may be moved distally such that the ends 502a, 504B of the links 500a, 500B, respectively, are separated, forming a second angle B therebetween, as shown in fig. 8. Angle B is greater than angle a. In some embodiments, angle a is about 35 ° and angle B is about 85 °. When the links 500a, 500b are separated, the wings 300a, 300b rotate about the pin 600 and bolt 700 into an open configuration.

The implant may then be moved proximally to engage wings 300a, 300b with bone and/or tissue at the implantation site, as can be seen in fig. 16. Nut 200 may then be moved proximally, such as by rotation, to engage bone and/or tissue and form a proximal anchor. Specifically, the nut 200 engages a first side surface 801 of the first spinous process 800 and a second side surface 804 of the second spinous process 802. In some embodiments, the flexing arms 214 can flex proximally when the nut 200 is in tight engagement with bone and/or tissue at the implant site. Additionally, the wings 300a, 300b engage a third opposing surface 803 of the first spinous process 800 and a fourth opposing surface 806 of the second spinous process 802. In particular, the teeth 310a, 311a, 310b, 311b of wings 300a, 300b may engage bone and/or tissue at the implantation site, forming a distal anchor. In some embodiments, wings 300a, 300b and nut 200 may be engaged on opposite sides of the spinous process when implant 100 is in place, as shown in fig. 16.

The features described above as well as those claimed below can be combined in various ways without departing from the scope hereof. The following examples illustrate some possible, non-limiting combinations:

(A1) A spinal implant, comprising: a body, a proximal anchor, a distal anchor, and an inner plunger. The body has an outer surface, a central bore therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The proximal anchor includes a nut having a proximal side, a distal side, and an interior bore. The distal anchor includes a plurality of wings having a first closed configuration and a second open configuration, wherein the plurality of wings includes a first wing and a second wing. The inner plunger has a proximal end, a distal end, and is received within the central bore of the body. The distal end of the inner plunger is operatively connected to the first wing and the second wing to selectively move the plurality of wings between the first closed configuration and the second open configuration.

(A2) For the spinal implant according to (A1), further comprising: a first link connecting the first wing to the inner plunger, wherein the first link has a proximal end and a distal end; and a second link connecting the second wing to the inner plunger, wherein the second link has a proximal end and a distal end.

(A3) For the spinal implant of (A2), the distal end of the inner plunger includes a first arm, a second arm, and a space between the first arm and the second arm, and the proximal end of the first link and the proximal end of the second link are mounted in the space between the first arm and the second arm of the inner plunger.

(A4) For the spinal implant of any one of (A2) to (A3), the first and second links are rotatably attached to the inner plunger by a mounting pin.

(A5) For the spinal implant of any one of (A2) to (A4), the distal end of the first link is connected to the first wing and the distal end of the second link is connected to the second wing.

(A6) For the spinal implant of any one of (A2) to (A5), the first wing includes a first slot for receiving the first link therein, and the second wing includes a second slot for receiving the second link therein.

(A7) For the spinal implant of any one of (A1) to (A6), the distal end of the first wing comprises at least one pointed projection adapted to engage tissue or bone.

(A8) For the spinal implant of any one of (A1) to (A7), the distal end of the second wing comprises at least one pointed projection adapted to engage tissue or bone.

(A9) For the spinal implant according to any one of (A1) to (A8), external threads are located on at least a portion of the outer surface of the body; and an internal thread is located within the internal bore of the nut, wherein the internal thread of the nut is configured to cooperate with the external thread of the body.

(A10) For the spinal implant of any one of (A1) to (A9), the distal side of the nut includes at least one flexing arm adapted to engage tissue or bone.

(A11) For the spinal implant of any one of (A1) to (a 10), the at least one flexure arm comprises a roughened surface or tooth adapted to engage tissue or bone.

(A12) For the spinal implant of any one of (A1) to (a 11), the proximal side of the nut includes a hexagonal extension.

(B1) A spinal implant comprising a body, a proximal anchor, a distal anchor, and a linkage assembly. The body has an outer surface, a central bore therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The body includes external threads on at least a portion of the outer surface. The proximal anchor includes a nut having proximal, distal and internal bores with internal threads. The distal anchor includes a first wing and a second wing configured to selectively open and close. The linkage assembly connects the first wing and the second wing to the body.

(B2) For the spinal implant of (B1), the linkage assembly comprises: an inner plunger, a first link, and a second link, the inner plunger being mounted within the central bore of the body.

(B3) For the spinal implant of (B2), the first link has a proximal end and a distal end and the second link has a proximal end and a distal end, and wherein the first link connects the first wing to the inner plunger and the second link connects the second wing to the inner plunger.

(B4) For the spinal implant of (B2) or (B3), the distal end of the inner plunger comprises a first arm, a second arm, and a space between the first arm and the second arm, wherein the proximal end of the first link and the proximal end of the second link are mounted in the space between the first arm and the second arm of the inner plunger.

(B5) For the spinal implant of any one of (B2) to (B4), the first and second links are rotatably attached to the inner plunger by a mounting pin.

(B6) For the spinal implant of any one of (B1) to (B5), the proximal side of the nut includes a hexagonal extension.

(C1) A method of placing a spinal implant at a treatment site, the method comprising: providing a spinal implant in a first closed configuration; placing the spinal implant at a desired treatment site within a patient; and sliding the inner plunger distally along the longitudinal axis to move the plurality of wings to the second open configuration. The method may further include sliding the inner plunger proximally along the longitudinal axis to move the plurality of wings to the first closed configuration to remove the spinal implant from the patient. The spinal implant includes a body, a proximal anchor, a distal anchor, and an inner plunger. The body has an outer surface, a central bore therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The proximal anchor includes a nut having a proximal side, a distal side, and an interior bore. The distal anchor includes a plurality of wings having the first closed configuration and a second open configuration, wherein the plurality of wings includes a first wing and a second wing. The inner plunger has a proximal end and a distal end, the inner plunger being received within the central bore of the body, the distal end of the inner plunger being operatively connected to the first wing and the second wing to selectively move the plurality of wings between the first closed configuration and the second open configuration.

(C2) For the method according to (C1), it further comprises: the inner plunger is slid proximally along the longitudinal axis to move the plurality of wings toward the first closed configuration to engage the plurality of wings with bone or tissue at the treatment site.

(C3) For the method according to (C1) or (C2), it further comprises: the nut is moved distally along the body to engage the distal side of the nut with tissue or bone.

(C4) For the method of any one of (C1) to (C3), sliding the inner plunger proximally along the longitudinal axis to move the plurality of wings to the first closed configuration to remove the spinal implant from the patient.

(C5) For the method of any one of (C1) to (C4), the proximal side of the nut further comprises a hexagonal extension.

Although the invention has been described with reference to the embodiments shown in the drawings, it should be noted that equivalents may be employed and substitutions made herein without departing from the scope of the invention as recited in the claims.

Having thus described various embodiments of the invention, what is claimed as new and desired to be protected by letters patent is included in the claims.

Claims

1. A spinal implant, comprising:

a body having an outer surface, a proximal end, a distal end, and a longitudinal axis extending therebetween, the body including a central bore therein;

a proximal anchor, the proximal anchor comprising: a nut having a proximal side, a distal side, and an interior bore;

a distal anchor, the distal anchor comprising: a plurality of wings having a first closed configuration and a second open configuration, wherein the plurality of wings includes a first wing and a second wing; and

an inner plunger having a proximal end and a distal end, the inner plunger being received within the central bore of the body, the distal end of the inner plunger being operatively connected to the first wing and the second wing to selectively move the plurality of wings between the first closed configuration and the second open configuration.

2. The spinal implant of claim 1, further comprising:

a first link connecting the first wing to the inner plunger, wherein the first link has a proximal end and a distal end; and

a second link connecting the second wing to the inner plunger, wherein the second link has a proximal end and a distal end.

3. The spinal implant of claim 2, wherein the distal end of the inner plunger comprises:

a first arm, a second arm, and a space between the first arm and the second arm,

wherein the proximal end of the first link and the proximal end of the second link are mounted in the space between the first arm and the second arm of the inner plunger.

4. A spinal implant as recited in claim 3, wherein the first and second links are rotatably attached to the inner plunger by a mounting pin.

5. A spinal implant as recited in claim 3, wherein the distal end of the first link is connected to the first wing and the distal end of the second link is connected to the second wing.

6. The spinal implant of claim 5, wherein the first wing includes a first slot for receiving the first link therein and the second wing includes a second slot for receiving the second link therein.

7. The spinal implant of claim 1, wherein the distal end of the first wing includes at least one pointed projection adapted to engage tissue or bone.

8. The spinal implant of claim 1, wherein the distal end of the second wing includes at least one pointed projection adapted to engage tissue or bone.

9. The spinal implant of claim 1, further comprising:

an external thread located on at least a portion of the outer surface of the body; and

an internal thread located within the internal bore of the nut,

wherein the internal thread of the nut is configured to cooperate with the external thread of the body.

10. The spinal implant of claim 1, wherein the distal side of the nut includes at least one flexing arm adapted to engage tissue or bone.

11. The spinal implant of claim 10, wherein the at least one flexure arm includes a roughened surface or tooth adapted to engage tissue or bone.

12. A spinal implant, comprising:

a body having an outer surface, a proximal end, a distal end, and a longitudinal axis extending therebetween, the body including a central bore therein and external threads on at least a portion of the outer surface;

a proximal anchor, the proximal anchor comprising: a nut having a proximal side, a distal side, and an internal bore, the internal bore having internal threads;

a distal anchor, the distal anchor comprising: a first wing and a second wing configured to selectively open and close; and

a linkage assembly connecting the first wing and the second wing to the body.

13. The spinal implant of claim 12, wherein the linkage assembly comprises:

an inner plunger, a first link, and a second link, the inner plunger being mounted within the central bore of the body.

14. The spinal implant of claim 13, wherein the first link has a proximal end and a distal end and the second link has a proximal end and a distal end, and

wherein the first link connects the first wing to the inner plunger and the second link connects the second wing to the inner plunger.

15. The spinal implant of claim 14, wherein the distal end of the inner plunger comprises a first arm, a second arm, and a space between the first arm and the second arm,

16. The spinal implant of claim 15, wherein the first and second links are rotatably attached to the inner plunger by a mounting pin.

17. A method of placing a spinal implant at a treatment site, the method comprising:

providing a spinal implant in a first closed configuration, the spinal implant comprising:

a distal anchor, the distal anchor comprising: a plurality of wings having the first closed configuration and a second open configuration, wherein the plurality of wings includes a first wing and a second wing; and

an inner plunger having a proximal end and a distal end, the inner plunger being received within the central bore of the body, the distal end of the inner plunger being operatively connected to the first wing and the second wing to selectively move the plurality of wings between the first closed configuration and the second open configuration;

placing the spinal implant at a desired treatment site within a patient; and

the inner plunger is slid distally along the longitudinal axis to move the plurality of wings to the second open configuration.

18. The method as recited in claim 17, further comprising:

the inner plunger is slid proximally along the longitudinal axis to move the plurality of wings toward the first closed configuration to engage the plurality of wings with bone or tissue at the treatment site.

19. The method as recited in claim 17, further comprising:

the nut is moved distally along the body to engage the distal side of the nut with tissue or bone.

20. The method as recited in claim 17, further comprising:

the inner plunger is slid proximally along the longitudinal axis to move the plurality of wings to the first closed configuration to remove the spinal implant from the patient.